【drug-news】FDA批准Viibryd (通用名维拉佐酮) 用于治
FDA NEWS RELEASE
For Immediate Release: Jan. 21, 2011
Media Inquiries: Sandy Walsh, 301-796-4669; firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves Viibryd to treat major depressive disorder
The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.
Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”
The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.
The drug will be available in 10, 20 and 40 milligram tablets.
Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.
Viibryd is manufactured by PGxHealth, New Haven, Conn. 北京东方凯恩医药科技有限公司采用渗透泵片新技术制成的维拉帕米择时释药系统已上市.新近,美国FDA批准了加拿大... 生物芯片的规范化、精确化和实用化已成现实并将广泛应用于生命科学、医药研究、环境...cang.baidu.com/...0b96490.html-2007-11-25-快照-医药科技有限公司" 钙离子拮抗剂 高血压论坛 - 高血压论坛 - 高血压治疗和饮食|...回帖数：9钙离子拮抗剂 钙拮抗剂在1962年即已被证实能有效地治疗急性高血压,70年代后期才被广... 所以它是ccb中对交感神经兴奋作用最小的药物,是目前fda惟一批准可用于心力衰竭患者的...bbs.idrug.cn/showtopic-2746... - 2009-12-19-快照-治疗和饮食|..." 中国2型糖尿病防治指南_1914849844_新浪博客糖尿病低血糖是指糖尿病药物治疗过程中发生的血糖过低现象,可导致患者 不适甚至生命... FDA仅 批准二甲双胍用于10岁以上儿童患者.用药应体现个体化,在多数情况下,特别 对...blog.sina.com.cn/...0nkpj.html-2011-01-12-快照-治指南_1914849844_新浪博客"[标签:content2]
作者:admin@医学,生命科学 2011-01-22 13:11